FDA Inspection
Argenta US Manufacturing LLCArgenta US Manufacturing LLC – FDA Inspection, Jun 10, 2010
Record Details
This FDA Inspection record concerns Argenta US Manufacturing LLC, with an inspection on June 10, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Argenta US Manufacturing LLC
- Inspection Date
- June 10, 2010
- Product Type
- Drugs
View Company Profile
ID · d4971a2f-d220-4840-bfe0-a7398371d824
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 670469
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.25(c)Inadequate number of personnel
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Argenta US Manufacturing LLC
11| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2026 | Not classified | Kansas City District Office | |
| July 24, 2026 | Not classified | Kansas City District Office | |
| December 15, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 14, 2022 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| August 1, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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